Z-2506-2024 Class II Ongoing

Recalled by Olympus Corporation of the Americas — Center Valley, PA

Recall Details

Product Type
Devices
Report Date
August 14, 2024
Initiation Date
May 31, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,838 Units

Product Description

Soltive SuperPulsed Laser System Wireless Footswitch, Model TFL-AFSWL

Reason for Recall

Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical procedure.

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Australia, Canada, Chile, Germany, Hong Kong, Japan, Singapore.

Code Information

Model: TFL-AFSWL; UDI-DI: 00821925044258; Serial Numbers: All Serial Numbers.